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2016年6月3-7日，一年一度的美国临床肿瘤学会（American Society of Clinical Oncology，ASCO）年会在芝加哥举办。6月4日上午的消化系统（非结直肠）肿瘤壁报专场上，杭州市肿瘤医院吴式琇教授呈现了一项摘要号为4048的中国研究，该研究是在食管鳞状细胞癌患者中开展的一项III期随机研究，将选择性淋巴结照射+厄洛替尼联合化疗进行比较，医脉通整理如下：

在不可切除的食管鳞状细胞癌（ESCC）治疗方面上，抗-EGFR治疗添加到化放疗以及选择性淋巴结照射（ENI）的价值没有被很好的定义。这项III期试验旨在确定厄洛替尼和/或ENI添加到包含顺铂/紫杉醇（CP）的并发常规化放疗中是否会改善生存期。

这项研究是一项2×2析因设计，厄洛替尼和ENI作为因素。研究人员将ESCC的中国患者随机分为：（A）ENI/CP/厄洛替尼；（B）ENI/CP；（C）常规区域辐射（CFI）/CP/厄洛替尼；（D）CFI/CP。主要终点是总生存期（OS）；次要终点包括无进展生存期，局部区域失败率，和毒性。如果两个因素之间没有相互作用被观察到，为了85%的P值检出0.76风险比（HR，每个因素的2-年OS率从35%到45%）需要342例患者和242例事件。

从2007年12月到2014年12月，352例患者被招募。在这次分析中所有患者的中位随访时间是16.5个月。ENI和厄洛替尼（P=0.999）两个因素之间没有显著的相互作用。2-年OS率和中位OS分别为：ENI（A+B）54%和35.4个月 vs CFI（C+D）42%和20.5个月（HR=0.69；95% CI，0.52-0.91；P=0.008）。2-年OS率和中位分别为：厄洛替尼（A+C）52%和24.9个月 vs 对照组（B+D）44%和20.9个月（HR=0.77；95% CI，0.57-1.00；P=0.049）。接受ENI联合厄洛替尼（A）治疗的患者达到58%的2-年OS率和47.2个月的中位OS。3级或以上的血液学毒性是最常见的不良事件。厄洛替尼会带来较高的各级皮疹事件发生率。

综上所述，与传统化放疗相比较，ENI或者厄洛替尼的添加会显著提高ESCC中国患者的生存期，在接受ENI+厄洛替尼治疗的患者中会取得最佳获益。不良事件发生率在这项研究中是可接受的。临床试验信息：NCT00686114。

会议专题》》》2016年ASCO年会专题报道

原文摘要：

Phase III randomized study of elective nodal irradiation plus erlotinib combined with chemotherapy for esophageal squamous cell carcinoma.(Abstract4048)

Authors：Shi Xiu Wu, Honglei Luo,et al

Session Type：Poster Session

Background: The addition of anti-EGFR therapy to chemoradiotherpay in the treatment of unresectable esophageal squamous cell carcinoma (ESCC) is not well defined, as well as the role of elective nodal irradiation (ENI). This phase III trial was designed to determine whether the addition of erlotinib and/or ENI to concurrent conventional chemoradiotherapy containing cisplatin/paclitaxel (CP) improved survival. 

Methods: This study was a 2x2 factorial design, with erlotinib and ENI as factors. We randomized Chinese patients with ESCC to: (A) ENI/CP/erlotinib; (B) ENI/CP; (C) conventional-field irradiation (CFI)/CP/erlotinib; (D) CFI/CP. The primary endpoint was overall survival (OS); secondary endpoints included progression-free survival, local-regional failure rate, and toxicity. Three hundred and forty-four patients and 242 events were needed for 85% power to detect a hazard ratio (HR) of 0.76 (2-year OS rate from 35% to 45% for each factor) if no interaction between the two factors was observed. 

Results: From December 2007 to December 2014, 352 patients were recruited. Median follow-up was 16.5 months for all patients at this analysis. There were no significant interactions between the two factors of ENI and erlotinib (P = 0.999). Two-year OS rate and median OS was 54% and 35.4 months for ENI (A+B) versus 42% and 20.5 months for CFI (C+D; HR = 0.69; 95% CI, 0.52 to 0.91; P = 0.008), respectively. Two-year OS rate and median OS was 52% and 24.9 months for erlotinib (A+C) versus 44% and 20.9 months for control (B+D; HR = 0.77; 95% CI, 0.57 to 1.00; P = 0.049), respectively. Patients treated with ENI plus erlotinib (A) achieved a 2-year OS rate of 58% and a median OS of 47.2 months. Hematologic toxicities grade 3 or above were the most common adverse events. Erlotinib was associated with a higher rate of all-grade rash events. 

Conclusions: Compared with conventional chemoradiotherapy, the addition of either ENI or erlotinib significantly improved survival among Chinese patients with ESCC, with the best of benefits in those treated with ENI plus erlotinib. The incidence rates of adverse-event were acceptable in this study. Clinical trial information: NCT00686114.

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